Status:
NOT_YET_RECRUITING
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Lead Sponsor:
Groupe Adène
Collaborating Sponsors:
Clinique Saint Jean, France
Institute of Neurosciences of Montpellier, INSERM U583
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
3-7 years
Brief Summary
The goal of this clinical trial is to learn if changes in quality of life are linked to changes in mouth opening after adenotonsillectomy in a group of children who were diagnosed with Type 1 Obstruct...
Detailed Description
STUDY BACKGROUND AND OBJECTIVES Obstructive Sleep Disordered Breathing (oSDB) encompasses a range of abnormal breathing patterns during sleep, from snoring to complete airway obstruction, caused by in...
Eligibility Criteria
Inclusion
- Age: 3 to 7 years old
- Received a surgical indication for adenotonsillectomy
- Beneficiary of the French single-payer national medical insurance system
- Informed consent given
- Able to attend all scheduled visits and comply with all trial procedures.
Exclusion
- Previous adenotonsillectomy
- Subject has already participated in the current study
- Craniofacial malformation syndrome
- BMI according to age \> 97th percentile
- Previous or current stimulant medication (methylphenidate)
- Current orthodontic treatment
- Asymmetric score of the tonsil with a tonsil Brodsky score of ≤2
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
Key Trial Info
Start Date :
October 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06973928
Start Date
October 15 2025
End Date
October 15 2026
Last Update
October 3 2025
Active Locations (1)
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1
Clinique Saint Jean
Saint-Jean-de-Védas, France, 34430